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Recruiting NCT06531473

Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures

No phase Interventional Urologic Diseases Prostate Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HoLEP.
Who it may be relevant to
Registry conditions: Urologic Diseases, Prostate Obstruction. Basic parameters: 18 years — 89 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Laser Outcomes Associated With HoLEP Procedures

Overview

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.

Interventions

  • Procedure HoLEP
    Patients will be randomized to one of the laser energy groups day of surgery.

Primary outcome measures

  • Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate. [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

Exclusion criteria

  • Prostates measurements over 200g
  • Patients who lack decisional capacity
  • Patients who are non-english speakers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Northwestern Medicine — Chicago

Identifiers

NCT: NCT06531473 · STU00220458

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗